1. Field of the Invention
The present invention relates to an ostomy appliance, and a method for the use of a body member and a body side ostomy member
2. Description of the Related Art
In connection with surgery for a number of diseases in the gastrointestinal tract a consequence is, in many cases, that the colon, the ileum or the urethra is exposed surgically and the patient is left with an abdominal stoma and the effluents or waste products of the body, which are conveyed through these organs, are discharged through the artificial orifice or opening and are collected in a collection bag, which is usually adhered to the skin by means of an adhesive wafer or plate having an inlet opening for accommodating the stoma. Also in connection with a fistula, the patient will have to rely on an appliance to collect the bodily material emerging from such opening.
Ostomy appliances are well known. Such appliances may be two-piece or one-piece appliances. In both types of appliances, a body side member is attached to the wearer""s abdomen, and optionally a receiving member or bag is attached to the body side ostomy member for receiving exudates from the ostomy in case of a two-piece appliance.
When using one-piece appliances, the whole appliance, including the adhesive wafer or pad securing the appliance to the skin is removed and replaced by a fresh appliance. When using two-piece appliances, the body side ostomy member is left in place for several days, and only the receiving member or bag is replaced.
The service time of the body side ostomy member depends on the amount and aggressiveness of the exudates and of the tightness between the ostomy and the body side ostomy member.
In the known appliances it is necessary to change the body side member of two-piece appliance when the center part of the adhesive wafer or pad has been sufficiently deteriorated to allow access of the aggressive exudates to the skin surrounding the stoma, irrespective of the fact that the wafer as such has a much longer wearing time. The access of aggressive exudates to the skin causes skin problems.
Skin problems are common for persons having a stoma. Generally, about 40% have skin problems (Pearl et al. 1985 xe2x80x9cEarly local complications from intestinal stomasxe2x80x9d, Arch. Surg. 120; 1145-1147) and the frequency is especially high for persons having an urostomy or ileostomy. About 80% of the persons having an ileostomy have skin problems (Hellman, J. D., Lago, C. P. 1990 xe2x80x9cDermatologic complications in colostomy and ileostomy patientsxe2x80x9d, International Journal of Dermatology, 29 (2); 129-133). The skin problems are most pronounced in a circular area about the stoma (xc2xd inch from the stoma) (Hellman and Lago 1990).
Frequent changing of the body side member of a two-piece appliance or the frequent exchange of a one-piece appliance is undesirable due to the irritation of the skin and the quality of life may be improved and the nuisance of the wearing of an ostomy appliance reduced if the intervals between exchanging of the body side member can be increased.
It is known to place a ring on the skin before applying the body side member or to make a filling between the edge of the stoma and the shaped whole of the ostomy appliance in order to form a seal between the stoma and the ostomy appliance in order to alleviate the problems using a commercially available medical grade adhesive paste. Such pastes are, e.g., sold by Bristol-Myers Squibb under the trademark STOMA HESIVE(copyright) or by Coloplast under the trade mark COLOPLAST(copyright) Paste.
These pastes, however, do not have a composition which has sufficient cohesion to ensure safe removal thereof without leaving residues on the skin and, on the other hand, the pastes often are so sticky that they cannot easily be shaped using the finger without sticking to the finger.
A paste should have a composition which is sufficiently tacky to secure the appliance or skin barrier to the abdomen, yet have a cohesion ensuring safe removal thereof without leaving residues on the skin. On the other hand, the paste must not be so sticky that it cannot easily be shaped by a finger or hand without sticking to the finger or hand. Furthermore, the paste must show a sufficient elasticity in order to be able to follow the movements of the patient without slipping on the skin and should also show a great resistance to erosion caused by aggressive exudates from an ostomy.
WO 92/18074 discloses a device in a stoma bandage comprising a sealing ring filled with a fluid to be applied around a stoma, the sealing ring being flexibly adjustable and having a variable diameter by the pressure of said liquid being increased or decreased for adjustment to the stoma of a user in order to seal between the stoma and the bandage. The sealing ring may be made of a material such as latex functioning as a septum through which an injection needle can be inserted in order to supply or remove fluid, respectively.
In GB Patent Application No. GB 2 290 974 is disclosed an ostomy appliance wherein a body-side member is combined with a mouldable mass of non-hypoallergenic, non-memory putty-like adhesive, particularly based on hydrocolloid or hydrogel.
GB Patent Application No. GB 2 290 974 discloses a body-side ostomy member comprising a ring to which a bag-side coupling ring or a bag can be attached, the ring comprising a rib and a flange, the flange being mounted on a wafer of medical grade adhesive having a central hole of diameter at least 65% of the internal diameter of the ring. A mouldable mass of non-hypoallergenic, non-memory putty-like adhesive, particularly based on hydrocolloid or hydrogel, is disposed radially inward of the wafer so that it forms a protective mass surrounding the stoma. The mouldable mass has a thickness of 1.25-3 times that of the wafer and a central hole therein of a diameter no more than {fraction (1/10)} th of the internal diameter of the ring. Both the medical grade adhesive and the mouldable adhesive are adhered to the skin.
European Patent application No. EP 0 686 381 discloses an ostomy appliance comprising a collection pouch and faceplate assembly including a flexible patch having a stoma-receiving opening, a first layer of skin friendly hydrocolloid-containing adhesive material along one side of the patch about the opening for securing said faceplate assembly to peristomal skin surfaces, and a second layer of relatively soft, easily deformable and extrudable, adhesive sealant material of a composition that is resistant to being dissolved or disintegrated by stomal fluids and that immediately surrounds the opening; the second layer being displaceable inwardly and axially into the opening for forming a stoma-engaging annular gasket to prevent stomal fluids from contacting the peristomal skin and the first adhesive layer.
The sealing ring disclosed in WO 92/18074 does not provide a safe seal against stomal liquids if not inflated to relatively high pressures which may cause irritation to the user.
The mouldable mass of non-hypoallergenic, non-memory putty-like adhesive or flexible patch disclosed in GB Patent Application No. GB 2 290 974 and European Patent application No. EP 0 686 381 both are secured to the rim of the hole for receiving the stoma.
The ostomy appliances disclosed in GB Patent Application No. GB 2 290 974 and European Patent application No. EP 0 686 381 both suffer from the drawback that the mouldable sealing material is only foreseen to be changed together with the body side member of the appliance. There is no teaching nor indication that the mouldable sealing material might be exchanged separately without removing the body-side member from the skin. Such separate exchange is not possible for either of the embodiments shown in the drawings of these applications.
It has surprisingly been found that it is possible to provide an ostomy appliance having a separate sealing member disposed in the hole of the wafer or pad surrounding the stoma offering a convenient and comfortable solution to the above problems.
None of the above mentioned patents describes the use of a separate sealing member which may be exchanged or substituted separately. Three different types of adhesives can be used for the sealing member, two of which are adaptable to the stoma without the use of tools.
1. Mouldable adhesives which can be adapted to the stoma by displacement, either inwardly or outwardly, of the adhesive mass.
2. Flexible adhesives which can be adapted to the stoma due to the flexibility and compliance whereby they form a protective layer on the peristomal skin surrounding the stoma.
3. Medical grade adhesives known per se but being supplied as a disc having an outer diameter corresponding to the hole in a body side ostomy member and being supplied with a pre-formed hole or for custom-adaptation or fit using a tool and/or a template for use as a sealing member.
This idea according to the invention differs from the above mentioned patents since the central ring in this case can be substituted without substituting the outer adhesive, which carries the bag.
The invention relates in a first aspect to an ostomy appliance comprising a body side member and a sealing member which is removable separately from the body side member when such is in use. More particularly, the body side member has a coupling flange and an adhesive wafer for securing the appliance to the skin, the wafer having a hole for receiving a stoma. The separate sealing member is disposed in the hole of the wafer for surrounding the stoma, and includes an adhesive portion and a backing. The adhesive portion of a hypo-allergenic moldable adhesive is in the form of a moldable mass with an outer diameter that corresponds to the hole in the body side member and an inner diameter defining a hole, the adhesive for adhering to the skin and sealing around the stoma and filling a void between the stoma and the body side member and having sufficient cohesion to be removed in one piece, independently of removal of the body side member when such is in use. The backing covers a surface of the adhesive portion and projects from the outer diameter of the adhesive portion to define a flange which prevents direct contact between exudates and the coupling flange of the body side member.
In a second aspect, the invention relates to an ostomy sealing member having an adhesive portion of hypo-allergenic adhesive in the form of a moldable mass with an outer diameter that corresponds to a hole in a body side ostomy member and an inner diameter defining a hole, the adhesive being adapted to adhere to skin and seal around an ostomy and fill a void between the ostomy and the body side ostomy member and which has a sufficient cohesion to be removed in one piece, independently of removal of the ostomy appliance when such is in use, without leaving remaining residue on the skin or the body side ostomy member. The sealing member also includes a backing which covers a surface of the adhesive and extends out from the outer diameter of the adhesive portion to define a flange which prevents direct contact between exudates and a coupling flange of the body side member during use thereof.
The sealing member may be applied to the abdomen together with the body side member or separately. When applying separately, the sealing member may be placed first and the body side member afterwards or, if desired, vice versa, provided that the outer diameter of the sealing member is smaller than the diameter of the hole in the body side member. Thus, a greater degree of freedom in placing the body side member around the stoma is obtained.